Sodium oxybate 'shows good results in fibromyalgia trial'
A new drug for fibromyalgia showed good results in the first of two Phase III clinical trials, its manufacturers have announced.
Jazz Pharmaceuticals and UCB said that sodium oxybate, a central nervous system depressant currently used to treat narcolepsy, significantly reduced pain and fatigue and improved daily function.
In the 14-week study, 548 fibromyalgia sufferers were divided into three groups. One was given 4.5g of sodium oxybate every night, the second was given 6g of the drug each night and the third was administered placebo.
Results showed that 46.2 per cent of patients in the first group reported an improvement of 30 per cent in pain, compared to 39.3 per cent and 27.3 per cent in the second and third groups respectively.
In addition, patients who were dosed at both levels reported a significant improvement in fatigue, while daily functioning considerably improved in the 4.5g/night group and approached significance in the 6g/night group.
Side effects of the drug noted were nausea, dizziness, vomiting, diarrhea, anxiety, and sinusitis. However, these symptoms were mild to moderate and the drug was generally well tolerated.
"There is a significant unmet need in diagnosing and treating millions of patients with fibromyalgia. Potential new treatments that address the various symptoms can have a significant impact on patients' quality of life," commented lead researcher Dr I Jon Russell of the University of Texas Health Centre.
A spokeswoman for the Arthritis Research Campaign said that effective drugs were much-needed for fibromyalgia, which remained a poorly understood condition.
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